Method for treating infectious organisms normally considered to be resistant to an antimicrobial drug
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example 1
Preparation of 1% Itraconazole Suspension with Deoxycholic Acid Coating
Each 100 mL of suspension contains:
[0096]
Itraconazole1.0 g (1.0% w / v)Deoxycholic Acid, Sodium Salt, Monohydrate0.1 g (0.1% w / v)Poloxamer 188, NF0.1 g (0.1% w / v)Glycerin, USP2.2 g (2.2% w / v)Sodium Hydroxide, NF (0.1 N or 1.0 N)for pH AdjustmentHydrochloric Acid, NF (0.1 N or 1.0 N)for pH AdjustmentSterile Water for Injection, USPQSTarget pH (range)8.0 (6 to 9)
Preparation of Surfactant Solution (2 Liters) for Microprecipitation
[0097]Fill a properly cleaned tank with Sterile Water for Injection and agitate. Add the required amount of glycerin and stir until dissolution. Add the required amount of deoxycholic acid, sodium salt monohydrate and agitate until dissolution. If necessary, adjust the pH of the surfactant solution with minimum amount of sodium hydroxide and / or hydrochloric acid to a pH of 8.0. Filter the surfactant solution through a 0.2 μm filter. Quantitatively transfer the surfactant solution to the vesse...
example 2
Preparation of 1% Itraconazole Nanosuspension with Phospholipid Coating
Each 100 mL of suspension contains:
[0106]
Itraconazole1.0 g (1.0% w / v)Phospholipids (Lipoid E 80)1.2 g (1.2% w / v)Glycerin, USP2.2 g (2.2% w / v)Sodium Hydroxide, NF (0.1 N or 1.0 N)for pH AdjustmentHydrochloric Acid, NF (0.1 N or 1.0 N)for pH AdjustmentSterile Water for Injection, USPQSTarget pH (range)8.0 (7.5 to 8.5)
Preparation of Surfactant Solution (2 Liters) for Microprecipitation
[0107]The surfactant solution is prepared in two phases. Phase 1 is dispersed phospholipids, whereas Phase 2 includes filtered glycerin. The two fractions are combined prior to pH adjustment.
[0108]Phase 1: Fill a properly cleaned vessel with approximately 700 mL of Sterile Water for Injection, USP (WFI) with agitation at 50-500 rpm. Increase the temperature of the filtrate to 50° C.-70° C. and add the required amount of phospholipids with mixing at 50-500 rpm until complete dispersion is achieved. Document the time and temperature at w...
example 3
Other Formulations of Itraconazole Suspensions
[0119]Other formulations of itraconazole suspensions with different combinations of the surfactants can also be prepared using the method described in Example 1 or Example 2. Table 1 summarizes the compositions of the surfactants of the various itraconazole suspensions.
[0120]
TABLE 1Summary of the compositions of thevarious 1% itraconazole suspensionsFormulation No.Surfactants in the formulationAmount*1Poloxamer 1880.1%Deoxycholate0.1%Glycerin2.2%2Poloxamer 1880.1%Deoxycholate0.5%Glycerin2.2%3Poloxamer 1882.2%Deoxycholate0.1%Glycerin2.2%4Poloxamer 1882.2%Deoxycholate0.5%Glycerin2.2%9Solutol0.3%Deoxycholate0.5%Glycerin2.2%14331-1Solutol1.5%Glycerin2.2%14443-1Albumin 5%14 Phospholipid2.2%Deoxycholate0.5%Glycerin2.2%Na2PO40.14% A6Phospholipid1.2%Glycerin2.2%BPhospholipid1.2%Glycerin2.2%N-methyl-2-pyrrolidinonetraceCPhospholipid1.2%Glycerin2.2%Lactic acidtrace14412-3Phospholipid1.2%Hydroxyethyl starch1.0%Glycerin2.2%TRIS0.06% *% by weight of...
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